The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe Vio Apc With Accessories.
| Device ID | K024047 |
| 510k Number | K024047 |
| Device Name: | ERBE VIO APC WITH ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ERBE USA, INC. 550 BELGRAVE LN. Tucker, GA 30084 |
| Contact | Julie Stephens |
| Correspondent | Julie Stephens ERBE USA, INC. 550 BELGRAVE LN. Tucker, GA 30084 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-09 |
| Decision Date | 2003-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147014725 | K024047 | 000 |
| 04050147001329 | K024047 | 000 |
| 04050147017313 | K024047 | 000 |
| 04050147000193 | K024047 | 000 |